Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease
Public ClinicalTrials.gov record NCT01647412. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately 20-30% develop this condition during childhood or adolescence, most of whom have Crohn's disease (CD). It appears that some individuals are genetically susceptible to certain nutrients, causing inflammation and disturbance of their immune system, as well as disruption of the intestinal barrier. This leads to malnutrition and inhibited growth, with many patients experiencing intense abdominal pain and diarrhea. Most physicians treat the disease with drugs that suppress the immune system and decrease the inflammatory process. Although these drugs frequently induce remission, most patients experience a subsequent return of symptoms and fail to catch up on their growth. Additionally, serious side effects are associated with these drugs. Individuals genetically prone to CD are believed to have a leaky gut that allows substances to pass through the intestinal wall and react with the underlying immune system. Furthermore, those nutrients that are toxic to these individuals pass through the decreased intestinal barrier triggering an extreme immune response. Nutrients that have been implicated include grains, except rice, dairy products, and any food containing carrageenan. Excluding these nutrients from the diet has been shown to beneficial for CD patients. Certain nutraceuticals, such as curcumin and omega-3 fatty acids, have been shown to provide anti-inflammatory effects in IBD patients. In addition, the administration growth hormone (GH), has been shown to alleviate symptoms, by enhancing the repair of the intestinal epithelium, preventing toxic antigens from reaching the underlying lamina propria. Previous studies and case reports provide incomplete evidence that exclusion diet with nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD, discontinuation of other CD drugs, and catch up growth. This study is designed to test this hypothesis. Patients in the treatment group will be treated with DNT and GH, while continuing to receive medications from their physician while the control group will receive DNT, placebo injections instead of GH. We predict that the treatment group will show greater improvement than the control group.
Study identification
- NCT ID
- NCT01647412
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- Not listed
Conditions and interventions
Conditions
Interventions
- Growth Hormone Drug
- Nutraceutical Combination Dietary Supplement
- Exclusion Diet Other
- Placebo Growth Hormone Other
Drug · Dietary Supplement · Other
Eligibility (public fields only)
- Age range
- 10 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2012
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Apr 12, 2015
Started 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Columbia University Department of Clinical Genetics | New York | New York | 10032 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01647412, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2015 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01647412 live on ClinicalTrials.gov.